21 CFR §111.315 — What are the requirements for laboratory control processes?

1. (a)Use of criteria for establishing appropriate specifications;
2. (b)Use of sampling plans for obtaining representative samples, in accordance with subpart E of this part, of:
   1. (1)Components, packaging, and labels;
   2. (2)In-process materials;
   3. (3)Finished batches of dietary supplements;
   4. (4)Product that you receive for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier); and
   5. (5)Packaged and labeled dietary supplements.
3. (c)Use of criteria for selecting appropriate examination and testing methods;
4. (d)Use of criteria for selecting standard reference materials used in performing tests and examinations; and
5. (e)Use of test methods and examinations in accordance with established criteria.